Study of a Topical Formulation for the Treatment and Prevention of Raynaud's Phenomenon Symptoms

Raynaud Disease Clinical Trial

Official title:

A Study of a Topical Formulation of Nitroglycerin, Vascana® (MQX-503), and Matching Vehicle in the Treatment and Prevention of Symptoms Associated With Raynaud's Phenomenon

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00934427
• Other study ID #: 09-001
• Status: Active, not recruiting
• Phase: Phase 3
• First received: June 26, 2009
• Last updated: July 19, 2010
• Start date: June 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: MediQuest Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Vascana, a novel topical formulation of nitroglycerin, is effective in the treatment and prevention of the symptoms associated with Raynaud's Phenomenon.

Description:

Raynaud's Phenomenon is a sometimes debilitating condition in which blood flow to the fingers or toes is compromised when a patient is exposed to cold or stress. Current therapies for Raynaud's are suboptimal because they are associated with significant side effects. In this study, patient responses to cold temperature exposures in a climate-controlled room after application of the study medication are measured.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of Raynaud's phenomenon as determined by a history of cold sensitivity with pain, numbness, and/or tingling along with pallor or cyanosis of the fingers

• a history of at least two Raynaud's events during a typical winter day

• must be willing to apply creams to fingers

• must be willing to undergo cold temperature exposure

• must be willing and able to stop certain medications

• must be willing to use effective contraception, if applicable

Exclusion Criteria:

• had a Raynaud's attack that required hospital or clinic intervention

• has allergies to nitroglycerin or topical medication ingredients

• has a history of migraine or chronic pain

• has an unstable medical problem that could interfere with the study

• had a heart attack or uncontrolled heart problems, hypertension, or hypotension in the past 3 months

• used any investigational drug in the past 4 weeks

• has significantly abnormal laboratory tests

• had certain major surgeries in the past 6 months

• has skin lesions on certain parts of the fingers

• women who are pregnant or nursing

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Raynaud Disease

Intervention

Drug:
• 0.9% nitroglycerin in TAM cream
0.5 g of Vascana (0.9% nitroglycerin in proprietary vehicle cream) is applied topically BID for one day before certain planned cold exposures, once just before same planned cold exposures, and, if needed, right after the start of symptoms during same planned cold exposures
• vehicle cream
0.5g of vehicle cream is topically administered BID for one day before certain planned cold exposures, once just before certain planned cold exposures, and, if needed, right after the start of symptoms during certain planned cold exposures

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Connecticut	Farmington	Connecticut
United States	Michigan State University	Grand Rapids	Michigan
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota	Minneapolis	Minnesota
United States	University of Medicine and Dentistry in New Jersey	New Brunswick	New Jersey
United States	Stanford University	Redwood City	California
United States	University of Toledo	Toledo	Ohio
United States	Carolina Arthritis	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MediQuest Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as measured by changes in severity of the Raynaud's symptom most bothersome to the individual patient (Pain, Numbness, or Tingling)		2 weeks	No
Secondary	Changes from baseline in severity of each Raynaud's symptom (Pain, Numbness, and Tingling)		2 weeks	No
Secondary	Changes from baseline in duration of Raynaud's attacks		2 weeks	No
Secondary	Changes from baseline in number of Raynaud's attacks		2 weeks	No
Secondary	Changes from baseline in the Raynaud's Condition Score		2 weeks	No
Secondary	Changes in the maximum reduction in skin temperature		2 weeks	No
Secondary	Changes from baseline in overall disease severity measures		2 weeks	No
Secondary	Changes in the time to return to baseline skin temperature		2 weeks	No